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RecruitingNCT06108492Updated Dec 3, 2024

A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)

A Phase 1 interventional study of SHR-2005 in Intermediate and High-risk Non-muscle Invasive Bladder Cancer, sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-03.

Sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 10 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
170
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.

02

Conditions studied

  • Intermediate and High-risk Non-muscle Invasive Bladder Cancer
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's planned enrollment of 170 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd. is the lead sponsor of 59 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
  2. ≥18 years of age, either sex;
  3. Previous pathological biopsy was diagnosed as intermediate or high-risk NMIBC ;
  4. ECOG performance status of 0-1;
  5. Life expectancy ≥ 2 years;
  6. Adequate bone marrow and organ function.

Exclusion criteria

Exclusion Criteria:

  1. Received TURBT or other surgical treatment or radiotherapy for bladder lesions within 2 weeks before the first administration;
  2. Patients who were receiving treatment in other clinical trials or less than 4 weeks from the end of the first administration in this study;
  3. History of serious cardiovascular and cerebrovascular diseases;
  4. Severe infection within 2 weeks prior to the first dose;
  5. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0;
  6. Oversize surgery or severe trauma within 4 weeks before the first use of research drugs;
  7. Previously received any TNFR agonist antibody therapy, such as OX40, CD137, CD27, CD357 antibodies.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
170 participants (estimated)

Study arms

  • Experimental
    SHR-2005

    Only one arm with SHR-2005

    Drug: SHR-2005

Interventions

  • DrugSHR-2005

    In dose Escalation: Four dose levels are preset. The administration cycle included 6 times of induction perfusion period and 15 times of maintenance perfusion period. In indication Expansion: Indications will be selected to evaluate preliminary efficacy.

06

What researchers measure

Primary outcomes

  1. Incidence of dose limiting toxicities (DLTs)

    Time frame: From Day 1 to Day 21

  2. Maximum tolerated dose (MTD)

    Time frame: From Day 1 to Day 21

  3. Incidence and severity of adverse events (AEs) ([CTCAE] v5.0)

    Time frame: From Day 1 to 90 days after last dose

  4. RP2D（Recommended Phase 2 dose）

    Time frame: From Day 1 to 90 days after last dose

Secondary outcomes

  1. PK parameter: Tmax of SHR-2005

    Time to maximum concentration of SHR-2005

    Time frame: approximately 24 months

  2. PK parameter: Cmax of SHR-2005

    Maximum concentration of SHR-2005

    Time frame: approximately 24 months

  3. PK parameter: AUC0-∞ of SHR-2005

    area under the concentration-time curve from time 0 to infinity of SHR-2005

    Time frame: approximately 24 months

  4. Immunogenicity of SHR-2005

    Anti- SHR-2005 antibody (ADA)

    Time frame: approximately 24 months

  5. Duration of response (DoR)

    Evaluated using RECIST 1.1

    Time frame: approximately within 36 months

  6. Disease control rate (DCR)

    Evaluated using RECIST 1.1

    Time frame: approximately within 36 months

  7. Progression-free survival (PFS)

    Evaluated using RECIST 1.1

    Time frame: approximately within 36 months

  8. Amount_recovered and Percent_recovered

    The Amount _ recovered and Percent _ recovered of SHR-2005 in urine after intravesical instillation.

    Time frame: approximately 24 months

07

Study locations

1 of 1 sites recruiting
  • Fudan University Zhongshan Hospital
    Shanghai, Shanghai 200032, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06108492
Lead sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Oct 31, 2023
Start date
Nov 28, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Dec 3, 2024

Study contacts

Shouwei Zhao
Contact
shouwei.zhao@hengrui.com
0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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